Reported May 15, 2013 · Terminated
Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under…
Olympus America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus America Inc. · 3500 Corporate Pkwy. · Center Valley, PA · 18034-0610
Is this the product you have?
- Olympus SurgMaster UES-40 electrosurgical unit ("UES-40")
- Product UsageDesigned for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment
- Lot codes and dates
- Model UES-40, all serial numbers prior to 7925334 that have not been upgraded.
- Amount recalled
- 608
Where it was sold
Why it was recalled
Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to operate associated with the Olympus SurgMaster electrosurgical unit, model UES-40 ("UES-40") when used in conjunction with the Olympus WA22557C electrode. The complaint investigations revealed that
This product could cause temporary or reversible health problems — stop using it.
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